NCT05033717

Brief Summary

This project will be a Randomized control trial conducted to check the effects of tissue flossing technique versus static stretching exercises of bicep muscle on pain, range of motion and function in patients with bicipital tendinitis, so that we can have best treatment option for them. Duration will be of 6 months. Purposive sampling will be done. Subjects fulfilling eligibility criteria from Allied hospital Faisalabad, will be randomly allocated in two groups via lottery method. Baseline assessment will be done. Group A participants will be given baseline treatment along with tissue flossing. Group B participants will be given stretching exercises along with baseline treatment for two weeks, 3 sessions per week. Post intervention assessment will be done via, Numeric pain rating scale(NPRS),Shoulder Pain And Disability Index (SPADI) and goniometric measurements of shoulder ranges. Data will be analyzed by using SPSS version 20.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

August 30, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 5, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2021

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

January 4, 2022

Status Verified

January 1, 2022

Enrollment Period

4 months

First QC Date

August 27, 2021

Last Update Submit

January 3, 2022

Conditions

Keywords

FlossingFlexibilityROMPrevention

Outcome Measures

Primary Outcomes (3)

  • Numeric pain rating scale

    The 11-point numerical pain rating scale (NPRS) is a measure of pain in which patients rate their pain ranging from 0 (no pain) to 10 (worst imaginable pain), and it has been shown to have concurrent and predictive validity as a measure of pain intensity.

    2nd Week

  • Shoulder pain and disability index

    A shoulder pain and disability index (SPADI) is used to measure the pain and disability associated with shoulder pathology. The SPADI is a self-administered index consisting of 13 items divided into two subscales: pain and disability. The SPADI is responsive to change and accurately discriminates among patients who are improved or worsened.

    2nd Week

  • Goniometer

    A goniometer is an instrument that measures the available range of motion at a joint. The term Goniometry is derived from two Greek words, gonia, meaning "angle" and metron, meaning "measurement

    2nd Week

Study Arms (2)

Group A

EXPERIMENTAL

Tissue Flossing Technique

Other: Tissue Flossing Technique

Group B

ACTIVE COMPARATOR

Static Stretching exercises

Other: Static Stretching Technique

Interventions

Subjects will receive tissue-flossing intervention on bicep muscle for 30 sec to 2 min with an occlusion pressure of 100 mmHg. After removal of flossing, participants will perform bicep strengthening exercises at an intensity of 30% of 1 RM with 6-8 rep, 4 sets for a single day and 3 days per week for 2 weeks in total.

Group A

Subjects will perform passive static stretching exercises of bicep muscle. Each stretch will last for 30 sec at 100% of stretch intensity with 4 reps for each, 1 set per day and 3 days per week for total duration of two weeks. After the application of static stretch, participants will perform bicep strengthening exercises at an intensity of 30% of 1 RM with 6-8 reps, 4 sets for a single day and 3 days per week for 2 weeks in total.

Group B

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Bicep tendinitis with age 18 to 45 years
  • Subjects with a history of repetitive overhead activities and pain in bicipital groove.
  • Recent history of adhesive capsulitis.
  • Chronic bicep weakness with history of recreational activities.
  • Recreational athletes with history of pain and difficulty in overhead movements

You may not qualify if:

  • Tumors of joint or bone.
  • latex allergy
  • Hypertension (i.e., resting systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg)
  • Venous thrombotic disease
  • Heart disease
  • Respiratory disease;
  • Dermatitis
  • Psychiatric condition e.g depression,
  • Recent history of shoulder fracture or humerus fracture.
  • Rheumatoid arthritis.
  • Osteoarthritis.
  • Hyper-laxity of shoulder joint.
  • Instability of shoulder
  • Neuromuscular disorder
  • Inflammatory disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Allied hospital Faisalabad, Pakistan

Faisalābad, Punjab Province, Pakistan

Location

Related Publications (8)

  • 1. Care IP, Renee Yacoub C. REHABILITATION FOLLOWING BICEPS BRACHII AND SUPRASPINATUS TENDINOPATHIES IN A 5-YEAR-OLD HAVANESE. 2019.

    BACKGROUND
  • Driller MW, Overmayer RG. The effects of tissue flossing on ankle range of motion and jump performance. Phys Ther Sport. 2017 May;25:20-24. doi: 10.1016/j.ptsp.2016.12.004. Epub 2016 Dec 12.

    PMID: 28254581BACKGROUND
  • Cheatham SW, Baker R. Quantification of the Rockfloss(R) Floss Band Stretch Force at Different Elongation Lengths. J Sport Rehabil. 2020 Mar 1;29(3):377-380. doi: 10.1123/jsr.2019-0034.

    PMID: 31094647BACKGROUND
  • 6. Kiefer BN, Lemarr KE, Enriquez CC, Tivener KA, Daniel T. A pilot study: perceptual effects of the voodoo floss band on glenohumeral flexibility. International Journal of Athletic Therapy and Training. 2017;22(4):29-33.

    BACKGROUND
  • Borda J, Selhorst M. The use of compression tack and flossing along with lacrosse ball massage to treat chronic Achilles tendinopathy in an adolescent athlete: a case report. J Man Manip Ther. 2017 Feb;25(1):57-61. doi: 10.1080/10669817.2016.1159403. Epub 2016 May 30.

    PMID: 28855793BACKGROUND
  • Ekeberg OM, Bautz-Holter E, Keller A, Tveita EK, Juel NG, Brox JI. A questionnaire found disease-specific WORC index is not more responsive than SPADI and OSS in rotator cuff disease. J Clin Epidemiol. 2010 May;63(5):575-84. doi: 10.1016/j.jclinepi.2009.07.012.

    PMID: 19836206BACKGROUND
  • Abbott JH, Schmitt J. Minimum important differences for the patient-specific functional scale, 4 region-specific outcome measures, and the numeric pain rating scale. J Orthop Sports Phys Ther. 2014 Aug;44(8):560-4. doi: 10.2519/jospt.2014.5248. Epub 2014 May 14.

    PMID: 24828475BACKGROUND
  • 5. Parish E. Joint and Muscle Flossing.

    BACKGROUND

Study Officials

  • Syed Shakil Ur Rehman

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2021

First Posted

September 5, 2021

Study Start

August 30, 2021

Primary Completion

December 15, 2021

Study Completion

December 30, 2021

Last Updated

January 4, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations